RecruitingPhase 4NCT06875258

PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)

PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0, a Multicentre, Randomized Clinical Trial (PEHAB-II)

Sponsor

The Netherlands Cancer Institute

Enrollment

198 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Summary

The PEHAB-II study is prospective, randomized trial designed to assess the effect of two different rehabilitation strategies on the recovery of erectile function in nerve sparing prostatectomy patients. The two rehabilitation strategies consist of 1)12 months daily doses of 100 mg Sildenafil combined with vacuum device (VED) therapy for 10 minutes a day, five times a week or 2) Standard of care: monotherapy with an on-demand dosage of 100mg Sildenafil. The study will be performed in multiple centers in the Netherlands.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a structured penile rehabilitation program after nerve-sparing robotic prostate removal surgery, to see if it can help men regain erectile function more effectively. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with prostate cancer and are scheduled for nerve-sparing robotic prostatectomy (surgical removal of the prostate) - Your cancer has not spread to lymph nodes or distant sites - You had adequate erections before surgery - You are motivated to participate in a rehabilitation program **You may NOT be eligible if...** - You have had prior penile surgery - Your cancer has spread beyond the prostate - You are not eligible for nerve-sparing surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSildenafil

Taken daily or on demand. First two weeks dosage of 75mg to manage side effects. If side effects are bearable, dosage will be adjusted to 100mg

DEVICEErectile vacuum device

5 days a week, generating 5 erections per day

Locations(3)

Canisius Wilhelmina Ziekenhuis

Nijmegen, Gelderland, Netherlands

Antoni van Leeuwenhoek hospital, Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Maasstad ziekenhuis

Rotterdam, South Holland, Netherlands

View Full Details on ClinicalTrials.gov

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NCT06875258

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